Vaginitis

KINDRA LAUNCHES FIRST-EVER COMPREHENSIVE VAGINAL HEALTH SYSTEM: THE DAILY V SYSTEM

Retrieved on: 
Monday, March 25, 2024

NEW YORK, March 25, 2024 /PRNewswire/ -- Today, Kindra, the sex-positive vaginal health brand, announced the launch of the first-ever comprehensive vaginal health product system - the Daily V System. The 4-part daily regimen of Kindra products includes: Daily Vaginal Lotion, V Relief Serum, Soothe Bath Soak and the Core Supplement meant to support vulvar and vaginal skin for optimal vaginal health and sexual wellness.

Key Points: 
  • NEW YORK, March 25, 2024 /PRNewswire/ -- Today, Kindra , the sex-positive vaginal health brand, announced the launch of the first-ever comprehensive vaginal health product system - the Daily V System .
  • The 4-part daily regimen of Kindra products includes: Daily Vaginal Lotion , V Relief Serum , Soothe Bath Soak and the Core Supplement meant to support vulvar and vaginal skin for optimal vaginal health and sexual wellness.
  • This hormone-free system is designed to provide targeted relief and support for daily vulvar and vaginal health needs.
  • As part of its launch of the Daily V System, Kindra has partnered with pelvic floor physical therapist Dr. Sara Reardon, known online as The Vagina Whisperer, on a video about the importance of a daily vaginal health regimen for long-term vulvovaginal health and comfort.

Biom Pharmaceutical Published Clinical Safety & Efficacy of VagiBiom® Microbiome-based Probiotic Suppositories for Intimate Women's Health

Retrieved on: 
Tuesday, February 27, 2024

Numerous studies suggest that a balanced vaginal microbiome is critical to long-term health and wellness.

Key Points: 
  • Numerous studies suggest that a balanced vaginal microbiome is critical to long-term health and wellness.
  • "We are excited to share the results of the VagiBIOM clinical study; the need for natural solutions in vaginal health is largely unmet.
  • The results of the current peer-reviewed published clinical trial reinforce the safety and efficacy of our product.
  • However, the current peer-reviewed clinical results further reinforce the safety and efficacy of our product,” said Biom's Founder & President, Dr. Bobban Subhadra.

Medicines360 and DKT WomanCare Announce Strategic Partnership to Expand Access to the Hormonal IUD Avibela™

Retrieved on: 
Wednesday, January 31, 2024

"As a global nonprofit pharmaceutical organization dedicated to expanding access to affordable reproductive health products for women, DKT WomanCare is an ideal partner for our organization," said Dr. Andrea Olariu, CEO of Medicines360.

Key Points: 
  • "As a global nonprofit pharmaceutical organization dedicated to expanding access to affordable reproductive health products for women, DKT WomanCare is an ideal partner for our organization," said Dr. Andrea Olariu, CEO of Medicines360.
  • “DKT WomanCare looks forward to leveraging our global partnerships and commercial relationships to ensure every woman, regardless of income, can access affordable, high-quality contraception.
  • As the supplier of AVIBELA, Medicines360 will focus on providing quality assurance and regulatory oversight, as well as ensuring sustainable product supply to DKT WomanCare and global procurement agencies.
  • Together, Medicines360 and DKT WomanCare will meet the growing demand for quality-assured, affordable hormonal IUDs and help build a robust and sustainable global contraceptive market.

Cepheid Receives Expanded FDA Clearance with CLIA Waiver for Xpert® Xpress MVP

Retrieved on: 
Thursday, January 18, 2024

SUNNYVALE, Calif., Jan. 18, 2024 /PRNewswire/ -- Cepheid announced today that it has received FDA Clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert® Xpress MVP. This multiplex vaginal panel can now be performed in near-patient settings, enabling results within 60 minutes from a single specimen for Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), and Trichomoniasis (TV). This expanded claim exemplifies Cepheid's commitment to providing expanded access to women's and sexual health by making PCR testing accessible at the point of care. The test runs on Cepheid's GeneXpert Xpress instruments and has been approved for testing women fourteen years of age and older.

Key Points: 
  • SUNNYVALE, Calif., Jan. 18, 2024 /PRNewswire/ -- Cepheid announced today that it has received FDA Clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert® Xpress MVP.
  • This expanded claim exemplifies Cepheid's commitment to providing expanded access to women's and sexual health by making PCR testing accessible at the point of care.
  • The test runs on Cepheid's GeneXpert Xpress instruments and has been approved for testing women fourteen years of age and older.
  • For more information about Cepheid's Xpert Xpress MVP test, please visit Cepheid's website.

Recce Pharmaceuticals Reports Positive Preclinical Data of RECCE® 327 Against Gonorrhea

Retrieved on: 
Monday, December 18, 2023

“The need for a new class of anti-infectives could not be greater, especially against a sometimes lethal pathogen, such as N. gonorrhoeae,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals.

Key Points: 
  • “The need for a new class of anti-infectives could not be greater, especially against a sometimes lethal pathogen, such as N. gonorrhoeae,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals.
  • After three days, the mice treated with R327 showed an approximate 4-log (99.99%) reduction in bacterial shedding, demonstrating significant bactericidal activity.
  • After five days of treatment, R327 showed a 3.5-log (>99.9%) reduction in bacterial shedding compared to the placebo-treated group.
  • A late-stage preclinical study comparing IV administration to a topical application of R327 against N. gonorrhoeae is underway.

GenSci Launches Global Innovation Hub in Shanghai

Retrieved on: 
Saturday, December 23, 2023

SHANGHAI, Dec. 22, 2023 /PRNewswire/ -- Changchun GeneScience Pharmaceutical ("GenSci"), a subsidiary of Changchun High-Tech Industries (Group), held a groundbreaking ceremony for its new global headquarters and research & development (R&D) center at Shanghai Zhangjiang International Medical Park on December 15th. With an increasing focus on women`s and children`s health, the Chinese government has been intensifying efforts to improve healthcare services for these demographics, embedding their care within the wider framework of the country's economic and social development policies. The establishment of the R&D center sets the stage for GenSci to further advance the convergence of industry, academia, research and the medical community. By leveraging cutting-edge R&D capabilities and the application of artificial intelligence technologies, GenSci is well-positioned to provide premium health solutions for women and children. The initiative aligns with GenSci's commitment to harnessing science and technology to protect and enhance the health of these vulnerable groups.

Key Points: 
  • SHANGHAI, Dec. 22, 2023 /PRNewswire/ -- Changchun GeneScience Pharmaceutical ("GenSci"), a subsidiary of Changchun High-Tech Industries (Group), held a groundbreaking ceremony for its new global headquarters and research & development (R&D) center at Shanghai Zhangjiang International Medical Park on December 15th.
  • Integrating AI technology, GenSci covers the entire drug innovation process, from initial design and screening to process development and formulation.
  • GenSci has formed enduring and robust partnerships with nearly 20 prominent universities, including Shanghai Jiao Tong University and Zhejiang University.
  • The groundbreaking of GenSci's global innovation hub and R&D center enpowers the company to fully utilize its expertise in gynecology and pediatrics.

Suzhou OSAI Biopharma Announces Positive Phase III Clinical Trial Results for Lactobacillus Crispatus Live Bacteria Capsule, Significantly Reducing Recurrence of Gynecological Infections

Retrieved on: 
Tuesday, December 12, 2023

Suzhou OSAI Biopharma, Inc., a biopharmaceutical company focused on developing live biotherapeutic products (LBPs), today announced that its Phase III clinical trial of vaginal L. crispatus live bacteria capsule (Lc262-1) has successfully met its primary and secondary endpoints.

Key Points: 
  • Suzhou OSAI Biopharma, Inc., a biopharmaceutical company focused on developing live biotherapeutic products (LBPs), today announced that its Phase III clinical trial of vaginal L. crispatus live bacteria capsule (Lc262-1) has successfully met its primary and secondary endpoints.
  • The Phase III study was a multicenter, randomized, double-blind, placebo-controlled trial that enrolled 320 patients with bacterial vaginosis (BV).
  • After receiving seven days of oral metronidazole and vaginal LBP/placebo combination therapy, the cured patients were followed up for three months.
  • “This Phase III clinical trial is the first registrational Phase III clinical trial globally to evaluate the efficacy of L. crispatus in reducing BV recurrence under a rigorous clinical design.

PHASE Scientific Americas Announces INDICAID Health™ At-Home Test Kits and Digital Health Platform

Retrieved on: 
Wednesday, October 25, 2023

PHASE Scientific Americas (PHASE Scientific), a fast-growing, global biomedical company developing innovative solutions to revolutionize healthcare diagnostics, announces INDICAID health™, its new line of at-home health tests and digital health experiences.

Key Points: 
  • PHASE Scientific Americas (PHASE Scientific), a fast-growing, global biomedical company developing innovative solutions to revolutionize healthcare diagnostics, announces INDICAID health™, its new line of at-home health tests and digital health experiences.
  • INDICAID health™ was created to help patients get back to better health faster and with less hassle.
  • “INDICAID health™ supports PHASE Scientific’s mission of shaping the future of at-home, personal diagnostics with people-first, science-based innovations,” said Felix Chao, General Manager of PHASE Scientific Americas.
  • The INDICAID health™ Sexual Health 2 test checks for the top two common STIs: Chlamydia and Gonorrhea.

Vulvovaginal Candidiasis Treatment Research Report 2023 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, October 10, 2023

The increasing demand for vulvovaginal candidiasis treatment can be attributed to several key factors driving its growth.

Key Points: 
  • The increasing demand for vulvovaginal candidiasis treatment can be attributed to several key factors driving its growth.
  • Furthermore, the global population's growing awareness of the need for effective yet cost-efficient treatment options, particularly among the elderly demographic, has led to a surge in demand for vulvovaginal candidiasis treatment on a global scale.
  • The market's growth is further driven by the rising prevalence of acute vulvovaginal candidiasis infections among the global population, with an increasing number of research initiatives aimed at understanding the prevalence of conditions like recurrent vulvovaginal candidiasis (RVVC).
  • Company Profiles: Detailed analysis of the major companies present in Global Vulvovaginal Candidiasis Treatment Market.

FDA Approves First Biosimilar to Treat Multiple Sclerosis

Retrieved on: 
Thursday, August 24, 2023

SILVER SPRING, Md., Aug. 24, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS).

Key Points: 
  • SILVER SPRING, Md., Aug. 24, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS).
  • "Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of multiple sclerosis," said Paul R. Lee, M.D., Ph.D., director of the Division of Neurology 2 in the FDA's Center for Drug Evaluation and Research.
  • This means patients can expect the same safety and effectiveness from the biosimilar as they would the reference product.
  • The FDA granted approval of Tyruko, the first biosimilar to Tysabri (natalizumab), to Sandoz Inc.